Industry validation

A company product quality is paramount for its prestige and its economic development. The demands of the markets and awareness of their rights by consumers, forcing manufacturing companies to face every day more competitive scenarios. This demand in quality as well as the need to optimize production processes has made it necessary to have fast and reliable analytical methods and that the manufacturing process is stable. Accordingly, statistical quality control is intended to monitor continuously, using statistical techniques, the stability of the process, and by means of control charts this analysis is carried out visually representing the variability of measurements for the presence of an excess of not expected variability by pure chance, and probably attributable to any specific cause that may investigate and correct. One of the tools that are available to ensure the quality of products and processes is the validation, thus, the adoption of a new analytical method must be supported by sufficient data laboratory and a well-documented validation, that meets the requirements. The validation process requires the statistical treatment for the management and analysis of the data allowing trials with criterion that lead to a correct evaluation. Methods of validation between validation methods used for different purposes are: the microbiological methods industrial processes validation validation analytical methods leads to ensure consistency of the process and product.

Week 1: introduction, analytical methods.

Week 2: microbiological methods

Week 3: processes of manufacture